Risk Management Integration: ISO 14971 in a QMSR World

How to develop, modify and use hazard analysis and the Product Risk Management File and Report per ISO 14971:2019 and ICH Q9 under the new device QMSRs.

The new 21 CFR 820, the QMSR for medical devices emphasizes risk management more than previous. The U.S. FDA has stated that the use of a medical devices entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify those risks, and take reasonable steps to mitigate them as far as practical and given the ‘state of the art’ at the time. ISO 14971 provides accepted methodologies emphasized more in ISO 13485, a major part of the new QMSR, to perform and document such an analysis as required by the FDA. This webinar will address the procedures, provide and discuss suggested templates, necessary to develop or modify and then use the ISO 14971 models to perform and document such activities for medical devices. It will outline the additional actions necessary to make it a useful product reference, CAPA, root cause / failure investigation, and validation prioritization and training tool, and how to maintain it as a “living document”. ISO 14971:2019's role  to include a company's entire QMS is emphasized.

Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product.  Product risk management is a required tool to drive and direct resource constrained product design, manufacture and validation activities in the company. High-profile field problems indicate that such activities are not yet adequately planned, executed, and visibility maintained. There is a failure to fully utilize the power of current risk management tools. Effective use of such risk management tools can help address the growing push by the public and the FDA, to “toughen” its approach to product clearance and approval, while reducing liability issues. A suggested Field-tested and audited over decades by both the FDA and Notified-Bodies "model" will be presented.

Areas Covered in the Session : 

• The Revised ISO 14971:2019 for Devices; key changes from 2007/9 
• The newly emphasized importance of risk in the QMSR
• Product Hazard Analysis
• Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
• Fault Tree Analysis - Yes use of FTA and FME[C]A are encouraged! 
• Suggested Risk Management File / Review, FMECA, FTA  Templates
• The Team and It’s Involvement – Who, When and How
• Using the Completed Document –  More of It’s Real Value “In the Loop”

Who Should Attend:

• Senior management in Devices, Combination Products
• Quality Assurance Departments
• Regulatory Affairs Departments
• Medical Device product development teams
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Marketing Departments
• Consultants; others tasked with leadership responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100,worldwide.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He has published numerous articles and book chapters (including 5 chapters in 2 RAPS V&V textbooks)  in peer reviewed publications, conducted workshops and webinars worldwide.  John is a graduate of UCLA.